FDA Device Guidances: Real-World Evidence, UDI, Adaptive Design, General Wellness – Drug and Device Digest

FDA BRIEF: Week of July 29, 2016

fda guidances



Real-World Data (RWD): Data collected from sources outside of traditional clinical

Real-World Evidence (RWE): Evidence derived from aggregation and analysis of
RWD elements.

FDA’s National Evaluation System leverages RWD to identify safety problems, to better understand the benefit-risk profile, reduce the time and cost of evidence generation


  • Of sufficient quality to provide confidence in analyses for regulatory decision making
  • May be used in total product life cycle e.g. generating clinical study hypotheses, historical control, concurrent control group, expand labeling, public health surveillance


  • Relevance: Ddata adequately addresses applicable regulatory question/ requirement
  • Reliability: Data accrual, Data adequacy, Data assurance

Comment period : End October.




Defines expected content and forms of the Unique Device Identifier (UDI) to assist both labelers and FDA-accredited issuing agencies

UDI Rule:

  • Create a standardized identification system for medical devices in US
  • Adequately identify devices through distribution and use

UDI Forms:

  • Easily readable plain-text
  • AIDC

UDI Content, Data delimiters

Comment period: End September




How to plan and implement adaptive designs for clinical studies when used in medical device development programs

Adaptive Designs:

  • prospectively planned modifications based on accumulating study data without undermining the study’s integrity and validity
  • efficient, saving time, money, and resources
  • can improve the chance of trial success by employing sample size reassessment
  • may facilitate transition from premarket to postmarket follow-up
  • can enhance patient protection
  • can include a plan to modify the patient population during the study
  • can improve decision-making at milestones
  • Limitations: more effort at the design stage, can introduce operational or statistical bias, may confound the interpretation,


  • control of the chance of erroneous conclusions (positive and negative)
  • minimization of operational bias

Adaptations Using Unblinded Data:

  • Group Sequential Designs, Sample Size Reassessment, Bayesian Sample Size Adaptation,  Group Sequential Designs etc.

Special Considerations:

  • Not Preplanned chnages, Simulations, Safety Endpoints,  Open-Label Randomized Studies, Observational Comparative Studies, One-Arm Studies without a Control


  • Data Monitoring Committees,  Minimize Operational Bias, IRBs, Logisitcs

Regulatory Considerations:

  • FDA interactions, Sponsor Monitoring, Protect Study Blinding



POLICY for low risk general wellness products

CDRH does not intend to examine

  • whether they are devices
  • whether they comply with the premarket review and post-market regulatory requirements for devices
  • whether they are implementing regulations : registration and listing, premarket notification, labeling, good manufacturing practice,  Medical Device Reporting

Must meet factors

  • intended for only general wellness use AND
  • present a low risk to the safety of users and other persons

Intended Use

  • Maintaining or encouraging a general state of health or a healthy activity
  • Relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions


Sustaining or offering general improvement to functions with general health

  • weight management, physical fitness, relaxation or stress management, mental acuity, self-esteem, .sleep management, sexual function

Sustaining or offering general improvement to functions associated with a general state of health while making reference to diseases or conditions

  • may help to reduce the risk of certain chronic diseases or conditions
  • may help living well with certain chronic diseases or conditions

QUESTIONNAIRE to determine fit






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